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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
DIASCREEN REAGENT STRIPS (K971976)Dia-Screen Corp.1997-06-17
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR (K971162)Genzyme Corp.1997-06-16
NIL - POWDER-FREE LATEX EXAMINATION GLOVES (K961634)Hl Rubber Products Sdn Bhd1997-06-16
POWDER-FREE LATEX EXAMINATION GLOVES (K964724)Pwa Industries Sdn. Bhd.1997-06-16
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) (K971952)Bio-Rad1997-06-16
ACTIVE TESTOSTERONE EIA (DSL-10-4000) (K971823)Diagnostic Systems Laboratories, Inc.1997-06-16
SPECIALITY URINE 1,2 (K971405)Chiron Diagnostics Corp.1997-06-16
MYCOPLASMA IGG ELISA TEST SYSTEM (K970150)Zeus Scientific, Inc.1997-06-16
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K971190)Genzyme Corp.1997-06-16
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902)Roche Diagnostic Systems, Inc.1997-06-16
OPTIM-EYES 450 (K971875)Taylor/Fox Enterprises, LLC1997-06-13
SUNGLASSES (NON-PRESCRIPTION) (K971707)Niko Sunglasses Corp.1997-06-13
DUALINE 400 CIC (K971158)Bernafon-Maico, Inc.1997-06-13
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) (K971087)W.J. Byrnes & Co. of Los Angeles, Inc.1997-06-13
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K964507)Roche Molecular Systems, Inc.1997-06-13
MITAYA ALUMINUM INTERSPACED X-RAY GRID (K964025)X-Ray Accessory Corp.1997-06-13
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (K971399)General Hearing Instruments, Inc.1997-06-13
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT (K971505)Beckman Instruments, Inc.1997-06-11
OLYMPUS CK-MB REAGENT (K971817)Olympus America, Inc.1997-06-11
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) (K971954)Bio-Rad1997-06-11
BREATH TAKER (K971887)Hofa, LLC1997-06-10
SCAR HEAL (K971468)Specialty Systems, Inc.1997-06-10
PHILIPS S1694, S1695 (K971804)Philips Hearing Instruments Co.1997-06-06
WIDEX SENSO DIGITAL (MINI CANAL) (K971535)Widex Hearing Aid Co., Inc.1997-06-06
RIONET HB-79P (K971693)Authorized Hearing Systems, Inc.1997-06-06
VISTA V-38 CIC (K970939)Vista Labs1997-06-06
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN (K970880)Micro-Ear Technology, Inc.1997-06-06
SCIENTIFIC PLASTICS MODEL SP (K971299)Scientific Plastics, Inc.1997-06-06
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K970735)Randox Laboratories, Ltd.1997-06-06
ANOKRYO (K964634)Mk Conquest Intl., Inc.1997-06-06
GLARE WARE (K970816)Ergovision, Inc.1997-06-05
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (K971465)National Healthcare Mfg. Corp.1997-06-04
ACS ESTADIOL-6 II (K970386)Chiron Diagnostics Corp.1997-06-04
PARAMAX CHOLESTEROL REAGENT (K964660)Dade Intl., Inc.1997-06-04
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018)Bio-Rad1997-06-04
TRI AUTO ZX (K970339)J. Morita USA, Inc.1997-06-04
STERILE SUREFLEX FILES AND INSTRUMENTS (K971603)Dentsply Intl.1997-06-04
SERIES XE, SERIES SE, SERIES TE (K971350)Micro-Mega Societe Anonyme1997-06-04
DUQIAO (K971551)Duqiao Glasses (Group) Co. , Ltd.1997-06-04
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES (K971424)Ansell Perry1997-06-04
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905)Beckman Instruments, Inc.1997-06-04
BIOACCESS MARROW HARVEST SYSTEM (K971114)Bioaccess, Inc.1997-06-03
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K (K971411)Bentec Medical, Inc.1997-06-03
STERILE FLEXOFILE FILES AND INSTRUMENTS (K971606)Dentsply Intl.1997-06-03
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (K971063)King Dental Corp.1997-06-03
OPALDAM (K971284)Ultradent Products, Inc.1997-06-03
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036)Interpore Intl.1997-06-03
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 (K971691)Bio-Rad1997-05-30
DMA TRIGLYCERIDES PROCEDURES (K971113)Data Medical Associates, Inc.1997-05-29
PATHFINDER SUNGLASSES (K971495)Coil1997-05-29
SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE (K971403)Sj Medical Products (M) Sdn Bhd1997-05-29
CHOL OR CHOLESTEROL (K971345)Carolina Liquid Chemistries Corp.1997-05-29
KASHA VISUAL FIELD SYSTEM (K971156)Kasha Software, Inc.1997-05-28
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) (K971544)Synthes (Usa)1997-05-28
NOTEBOOK IMAGER (K961104)Digirad Corp.1997-05-28
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER (K970828)United Hearing Systems, Inc.1997-05-28
IMMULITE PYRILINKS-D (K971312)Diagnostic Products Corp.1997-05-27
QUANTEX ASO-CRP-RF CONTROL (K971777)Instrumentation Laboratory CO1997-05-27
ORTHOCHUCK (K964252)Buckman Co., Inc.1997-05-27
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K971485)Trace America, Inc.1997-05-27
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE (K971415)Shanghai Foremost Plastic Industrial Co., Ltd.1997-05-23
ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (K971100)Atrion Medical Products, Inc.1997-05-23
VINYL PATIENT EXAMINATION GLOVE, POWDERED (K971423)Shanghai Foremost Plastic Industrial Co., Ltd.1997-05-23
ML DISPOSABLE ALK TUBING (K971173)Med-Logics, Inc.1997-05-22
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (K971319)Tycom Dental1997-05-22
AYURVEDIC TONGUE CLEANER (K971025)Calello Martinez P.C.1997-05-22
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL (K971534)Beckman1997-05-21
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919)Beckman Instruments, Inc.1997-05-21
ROCHE COBAS AMPLICOR ANALYZER (K964506)Roche Molecular Systems, Inc.1997-05-21
ACE HDL-C REAGENT (K971526)Schiapparelli Biosystems, Inc.1997-05-21
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (K970873)American Medical Devices, Inc.1997-05-20
SCOPETEX(TM) (K945590)Smith Helms Mulliss & Moore, L.L.P.1997-05-20
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702)Euclid Systems Corp.1997-05-20
WHITE RIVER MINI MANUAL BREAST PUMP (K971231)White River Concepts1997-05-19
HERO 642 (K970649)Micro-Mega1997-05-16
DSL ESTRONE-SULFATE RIA (K970915)Diagnostic Systems Laboratories, Inc.1997-05-16
QUANTUM 3080SP SURGICAL TABLE (K971390)STERIS Corporation1997-05-15
ODYSSEY I DENTAL WATER UNIT (K964796)Germiphene Corp.1997-05-14
EPISTAXIS NASAL PACK (K971000)Invotec International, Inc.1997-05-14
SUNGLASSES (K971412)Team Chien Industrial Co., Ltd.1997-05-13
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES (K970699)Yeong Jiuh Corp.1997-05-13
DSL ACTIVE NON-EXTRACTION IGF-I ELISA (K971353)Diagnostic Systems Laboratories, Inc.1997-05-12
SPECTRUM DESIGNS SPECTRAGEL (K970702)Spectrum Designs, Inc.1997-05-12
INNOFLUOR TOPIRAMATE CONTROL SET (K970517)Oxis Intl., Inc.1997-05-12
GE ADVANTAGE DIGITIZER WORKSTATION (K970628)Ge Medical Systems, Inc.1997-05-12
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781)Beckman Instruments, Inc.1997-05-09
WINMAX SOFTWARE SYSTEMS (K965103)Diagnostic Products Corp.1997-05-09
UNIKA (K971327)Eyewear Partners Co.1997-05-09
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR (K971389)Pdg Product Design Group, Inc.1997-05-09
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (K970441)Medi-Flex Hospital Products, Inc.1997-05-09
UNITRON MODEL SOUND F/X CIC (K970692)Unitron Industries, Inc.1997-05-08
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317)National Healthcare Mfg. Corp.1997-05-08
DERMAMEND FOAM ISLAND DRESSING (K970600)Dermarx Corp.1997-05-08
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN (K971249)Andrew G. Halpern1997-05-06
ARROW COMPANY (K971326)Excel Eyewear Corp.1997-05-06
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) (K970794)Siam Sempermed Corp., Ltd.1997-05-06
SOLAR SPECS (K970759)Morris Rosenbloom & Co., Inc.1997-05-06
CLASSIC MATCH (K971104)Delagar Division Belcam, Inc.1997-05-06
INSTRUMENT TRAY LINER (K971217)General Hospital Supply Corp.1997-05-06
LAXIMA INTERNATIONAL LIMITED SUNGLASSES (K970454)Laxima Intl., Ltd.1997-05-06
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